Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVETIRACETAM
SYNERRV SDN BHD
LEVETIRACETAM
3 x 10 Tablets
Jubilant Generics Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ JUBLEVET LEVETIRACETAM TABLETS 500MG Levetiracetam (500mg) 1 WHAT IS IN THIS LEAFLET 1. What JUBLEVET is used for 2. How JUBLEVET works 3. Before you use JUBLEVET 4. How to use JUBLEVET 5. While you are using it 6. Side effects 7. Storage and Disposal of product name 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IS JUBLEVET USED FOR JUBLEVET is used to control epilepsy. Epilepsy is a condition where you have repeated seizures (fits). There are many different kinds of seizures that can be mild or severe in nature. JUBLEVET can be used alone or in combination with other medicines to treat your condition. Alone, JUBLEVET is used in treatment of newly diagnosed epilepsy in patients from 16 years and older. JUBLEVET is used in patients who are already taking other anti-epileptic medicines: For treating partial seizures in adults and children from 4 years of age. For treating myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. For treating primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalized Epilepsy. HOW JUBLEVET WORKS JUBLEVET contains the active ingredient levetiracetam, which belongs to a group of medicines called anti-epileptics. It is thought to control brain chemicals which send signals to nerves, so that seizures do not occur. BEFORE YOU USE JUBLEVET _-When you must not use it _ Do not use JUBLEVET if you are allergic to: Any medicine containing levetiracetam. Medicines derived from a chemical called pyrrolidine (e.g. piracetam) or any of the ingredients that are listed here. If you are unsure about the use of JUBLEVET, please consult your doctor or pharmacist for further advice. _Pregnancy and lactation _ Tell your doctor if you are pregnant, planning to become pregnant or are currently breast-feeding. Your doctor will determine if it is alright for you to take JUBLEVET during pre Lesen Sie das vollständige Dokument
6401 Last modified: 6. July 2021, 12:30 PM SITE PACKAGING DEVELOPMENT SIGN AND DATE PRODUCTION SIGN AND DATE QA SIGN AND DATE ITEM CODE: 50000001587 SUPERSEDED ITEM CODE: NA PHARMA CODE: 6401 SUBSTRATE: 40 GSM BIBLE PAPER OPEN (LXW): 420 X 240 MM FOLDED (LXW): 62 X 31 MM FOIL WIDTH: NA PRINT REGISTRATION: NA CARTON (LXWXH): NA PIL/ MEDICATION GUIDE LABEL (LXW): NA COMPONENT: PIL CLIENT & COUNTRY : SYNERRV SDN. BHD., MALAYSIA REFERENCE SPEC NO: PS2860 SPECIAL INSTRUCTION (IF ANY): NA PANTONE: MARKET: ROW REASON FOR ARTWORK: NEW BLISTER (LXW): NA DIMENSION BLACK DIELINE FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A LABORATORY ONLY JUBLEVET LEVETIRACETAM TABLETS 500 MG 1. PRODUCT NAME: Levetiracetam Tablets 500 mg 2. NAME AND STRENGTH OF ACTIVE INGREDIENT: EACH FILM-COATED TABLET CONTAINS: Levetiracetam Ph.Eur. 500 mg 3. PRODUCT DESCRIPTION: LEVETIRACETAM TABLET 500 MG: Yellow coloured, oblong shaped, film coated tablets, with a scoreline on one side and debossed with ‘500’ on the other side of the tablet. 4. PHARMACODYNAMICS / PHARMACOKINETICS: PHARMACODYNAMIC PROPERTIES Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect. The primary metabolite is inactive. In man, an activity in both partial and generalised epilepsy conditions (epileptiform discharge/ photoparoxysmal response) has confirmed the broad spectrum pharmacological profile of levetiracetam. PHARMACOKINETIC PROPERTIES Levetiracetam is a highly soluble and permeable compound. The pharmacokinetic profile is linear with low intra- and inter-subject variability. There is no modification of the clearance after repeated administration. There is no evidence for any relevant gender, race or circadian variability. The pharmacokinetic profile is comparable in healthy volunteers and in patients with epilepsy. Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of levetiracetam expressed as mg/kg Lesen Sie das vollständige Dokument